• Precautionary labeling, however, is only available when the presence of allergen cannot be avoided by
GMPS
– “may contain milk”
– “processed on shared equipment with peanuts”
– “processed in a facility that processes peanuts

• We are finding major food allergens where we did not expect to find them (peanut in a ‘natural flavor’, fish extract as a carrier in colors)

• FDA never established “thresholds”

• What is the legal standard to apply?
– Is it “possibility of illness,” which is the standard FDA appears to be adopting?
– Should it be “cause an allergic response that poses a risk to human health?”
– Shouldn’t there be a recognition that if there is only a theoretical possibility of a mild reaction that such a reaction does not pose a risk to human health?”

• We will continue to find allergen in unexpected places and if they are detectable and not declared, there
will be recalled liability

• Companies may gravitate to precautionary labeling to avoid the costs of a recall